Completed

NCT Number: NCT02133300

NMES in Critically Ill Patients

Critically ill patients with a predicted prolonged ICU stay will receive neuromuscular electrical stimulation (NMES) of one quadriceps muscle. Whether the dominant or non-dominant side will be stimulated is chosen randomly by using opaque sealed envelopes. The patients will receive electrical stimulation for 1h for 7 consecutive days. The stimulated and non-stimulated side will be compared for it's thickness (by using ultrasound imaging), muscle strength if the patients are awake and cooperative (using the medical research council scale and handheld dynamometry) and a muscle biopsy will be taken. As a primary outcome the investigators hypothesize that electrical stimulation will preserve muscle mass with respect to the non-stimulated quadriceps. As secondary outcomes the investigators hypothesize that electrical stimulation can reduce muscle strength loss and leads to a better protein balance and thicker muscle fibers in the stimulated quadriceps.

Completed

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Key information

Conditions

Critically Ill Patients With a Predicted Prolonged ICU Stay

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3001, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All adult ICU patients with a predicted prolonged ICU stay

Exclusion criteria

Preexisting neuromuscular disease, polyneuropathy or myopathy (e.g. Guillain-Barré, myasthenia gravis, Amyotrophic Lateral Sclerosis, paraplegia, multiple sclerosis, …)
Receiving neuromuscular blocking agents
Musculoskeletal conditions of the pelvis and/or lower limb (e.g. fractures, skin disease )
Focal neurological conditions of the pelvis and/or lower limb
Skin disease (e.g. burns)
Presence of a pace-maker or defibrillator
Hemodynamic or Respiratory Instability, active cardiac ischemia
High fever (>39°)
Pregnancy
Brain death
Intracranial pressure >20 mmHg
An anticipated fatal outcome
Psychiatric disorders or severe agitation
Re-admission to the ICU

Treatment and study plan

Electrical Stimulation

Other

Primary outcomes

Muscle thickness

Time frame: pre-intervention period

Ultrasound measure in cm
Muscle thickness

Time frame: post intervention period

Ultrasound measure in cm

Secondary outcomes

Muscle strength (MRC & HHD)

Time frame: pre intervention period

MRC: scale HHD: MicroFet, in kg Force
Muscle fiber thickness

Time frame: post intervention period

biopsy using Bergström-Stille 5mm needles
Muscle strength (MRC & HHD)

Time frame: post intervention period

MRC: scale HHD: MicroFET, in kg Force
Protein balance

Time frame: post intervention

biopsy using Bergström-Stille 5mm needles

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

Neuromuscular Electrical Stimulation in Critically Ill Patients

Acronym: NESCI

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: May 8, 2014
Registry last updated: Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.